A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses

• ClinicalTrials.gov Identifier: NCT03684928
• Recruitment Status: Completed
• First Posted: September 26, 2018
• Results First Posted: June 26, 2020
• Last Update Posted: June 26, 2020
• Sponsor: Coopervision, Inc.
• Information provided by (Responsible Party): Coopervision, Inc.

Study Description

Brief Summary:

The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.

Condition or disease	Intervention/treatment	Phase
Astigmatism Bilateral	Device: Comfilcon A (test); Device: Senofilcon C (control)	Not Applicable

Detailed Description:

This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Prospective, double-masked, bilateral, randomized, one month cross-over dispensing study.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Bilateral Dispensing Comparison of Biofinity Toric and Acuvue Vita for Astigmatism
• Actual Study Start Date: July 23, 2018
• Actual Primary Completion Date: December 14, 2018
• Actual Study Completion Date: February 1, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Comfilcon A (test); Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.	Device: Comfilcon A (test); Daily wear contact lenses; Device: Senofilcon C (control); Daily wear contact lenses
Active Comparator: Senofilcon C (control); Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.	Device: Comfilcon A (test); Daily wear contact lenses; Device: Senofilcon C (control); Daily wear contact lenses

Outcome Measures

Primary Outcome Measures :

1. Ease of Insertion(Handling) [ Time Frame: Baseline ]
   Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
2. Ease of Insertion (Handling) [ Time Frame: 2 weeks ]
   Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
3. Ease of Insertion(Handling) [ Time Frame: 1 month ]
   Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)

Secondary Outcome Measures :

1. Rotational Recovery After Lens Mislocation [ Time Frame: Baseline ]
   Lens relocation after 10 blinks, after 30º rotation mislocation
2. Rotational Recovery After Lens Mislocation [ Time Frame: 1 month ]
   Lens relocation after 10 blinks, after 30º rotation mislocation.

Eligibility Criteria

• Ages Eligible for Study: 17 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has had a self-reported oculo-visual examination in the last two years.
3. Has read and signed an information consent letter;
4. Is willing and able to follow instructions and maintain the appointment schedule;
5. Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
6. Is willing to wear contact lens in both eyes for the duration of the study;
7. Has a minimum astigmatism of - 0.75, determined by refraction;
8. Can be fit with the two study contact lens types in the powers available;
9. Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
10. Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
11. Has clear corneas and no active* ocular disease;

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical trial;
2. Has any known active* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study measure;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
5. Has known sensitivity to fluorescein dye or products to be used in the study;
6. Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
8. Is aphakic;
9. Has undergone refractive error surgery;
10. Has participated in the previous QUENA study.

Contacts and Locations

Locations

Canada, Ontario

University Of Waterloo

Waterloo, Ontario, Canada, N2L 3G1

Sponsors and Collaborators

Coopervision, Inc.

Investigators

• Principal Investigator: Lyndon Jones, PhD FCOptom; Director, Centre for Ocular Research and Education

  Study Documents (Full-Text)

Documents provided by Coopervision, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] June 19, 2018

More Information

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03684928
• Other Study ID Numbers: EX-MKTG-94
• First Posted: September 26, 2018
• Results First Posted: June 26, 2020
• Last Update Posted: June 26, 2020
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Astigmatism; Refractive Errors; Eye Diseases